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Long Term (1 Year) Respiratory Sequelae in Children Surviving an Acute Respiratory Distress Syndrome

NCT ID: NCT01435889

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to assess long term (1 year) respiratory sequelae in children surviving an acute respiratory distress syndrome

Detailed Description

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The acute respiratory distress syndrome (ARDS) has a high mortality rate in children. Adverse long term sequelae, and in particular respiratory sequelae, have been described mainly in adults. Decrease in diffusing capacity, lung volume and exercise tolerance were observed. Lung function parameters improve during the follow-up until 6 month after discharge from the pediatric intensive care unit (PICU). After that, abnormalities in PFT are observed in a significant proportion of patients. Only two studies described long-term sequelae in children surviving to an ARDS and their results are conflicting. Two studies carried out in adults described the morphologic long-term sequelae by thoracic computed tomography. They showed reticular pattern with a striking anterior distribution in most patients evaluated more than 6 months after discharge from the PICU. There is, to our knowledge, no study describing morphologic pulmonary sequelae by thoracic computed tomography in children surviving to ARDS.

Respiratory assessment: respiratory sequelae in children surviving to the acute respiratory distress syndrome will be evaluated 1 year after discharge from the PICU. Assessment will include a clinical evaluation (respiratory history and physical examination), respiratory function tests and thoracic computed tomography

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* children surviving to an acute respiratory distress syndrome and alive 1 year after discharge from the PICU

Exclusion Criteria

* children suffering from neuromuscular disease
* children presenting symptoms of chronic respiratory disease before ARDS
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis Leclerc, MD

Role: STUDY_CHAIR

University hospital of Lille , France

Locations

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Hôpital Universitaire des Enfants Reine Fabiola, Université Libre de Bruxelles,

Brussels, , Belgium

Site Status

Hôpital Jeanne de Flandre, Centre Hospitalier Régional et Universitaire de Lille

Lille, , France

Site Status

Hôpital Trousseau, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status

Hôpital Robert Debré, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status

Hôpital Necker-Enfants Malades, Assistance Publique Hôpitaux de Paris

Paris, , France

Site Status

Countries

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Belgium France

References

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Neve V, Sadik A, Petyt L, Dauger S, Kheniche A, Denjean A, Leger PL, Chalard F, Boule M, Javouhey E, Reix P, Canterino I, Deken V, Matran R, Leteurtre S, Leclerc F. Whole pulmonary assessment 1 year after paediatric acute respiratory distress syndrome: prospective multicentre study. Ann Intensive Care. 2022 Aug 20;12(1):79. doi: 10.1186/s13613-022-01050-4.

Reference Type DERIVED
PMID: 35986824 (View on PubMed)

Other Identifiers

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PHRC 2005/R-1906

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PHRC 2005/R-1906

Identifier Type: -

Identifier Source: org_study_id